POLICY DOCUMENT MEDICAL DEVICES POLICY. Burton Hospitals NHS Foundation Trust. On: 30 May Review Date: March Corporate / Directorate

Transcription

1 POLICY DOCUMENT Burton Hospitals NHS Foundation Trust MEDICAL DEVICES POLICY Approved by: Trust Executive Committee On: 30 May 2017 Review Date: March 2020 Corporate / Directorate Clinical / Non Clinical Department Responsible for Review: Corporate Non Clinical Medical Engineering (EBME) Distribution: Essential Reading for: Information for: All users of medical devices All Clinical Staff Policy Number: Version: 83 7 Signature: Chief Executive Date : 30 May 2017 Medical Devices Policy (83) / Version 7 / March 2017

2 Burton Hospitals NHS Foundation Trust POLICY INDEX SHEET Title: Medical Devices Policy Original Issue Date: Prior to 2005 Date of Last Review : March 2017 Reason for amendment: Review Responsibility: The Medical Engineering Manager Stored: Intranet access: Corporate Non-medical Policies Linked Trust Policies: Electrical Safety Policy Incident and Serious Incident Management Policy Infection Prevention & Control Policy Disposal of Surplus/Obsolete/Condemned Equipment Policy Medical Devices Training Policy E & D Impact assessed EIA 138 Responsible Group / Committee Consulted Medical Devices & Product Users Group Members of the Medical Devices & product User Group Executive, Associate and Clinical Directors Medical Devices Policy (83) / Version 7 / March 2017

3 REVIEW AND AMENDMENT LOG Version Type of change Date Description of Change 6 Review Jul 2013 Updated 7 Review Mar 2017 Updated Medical Devices Policy (83) / Version 7 / March 2017

4 MEDICAL DEVICES POLICY CONTENTS PAGE Paragraph Number Subject Page Number 1 Introduction 1 2 Medicines & Healthcare products Regulatory Agency (MHRA) 1 3 Definition 2 4 Medical Device Categories Duties Disciplinary Action 6 7 Authorised Management Agencies Acceptance Procedure Devices on Loan, on Trial or Hired Testing, Decontamination and Maintenance of Loan Devices Prescription Devices Checklist for Patients Discharged With a Medical Device Labelling Maintenance & Repair Training Decontamination and Transfer of Devices Surgical Instruments and Equipment Adverse Incidents Disposal Effective Monitoring Policy Review 21 Medical Devices Policy (83) / Version 7 / March 2017

5 Burton Hospitals NHS Foundation Trust MEDICAL DEVICES POLICY 1. INTRODUCTION 1.1 It is the policy of Burton Hospitals NHS Foundation Trust that all medical devices, from initial acquisition to eventual disposal, for use within the Trust are safe and fit for their intended purpose. Each device will be maintained and managed appropriately to ensure that any associated risk to patient, staff or property is minimised. 1.2 The Trust s management is responsible for ensuring that procedures and protocols are in place and sufficiently robust to enable appropriate operation and management of medical devices. 1.3 Effective management of medical devices from initial selection to eventual disposal requires the full co-operation of the clinical, laboratory, purchasing, medical engineering, and finance departments. 2. MEDICINES & HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA) 2.1 Medicines & Healthcare Products Regulatory Agency is an executive agency of the Department of Health, whose objective is to ensure that all medical products, devices and equipment are of safe design, appropriate quality, perform as intended, are properly stored, used and correctly maintained. 2.2 The Trust s nominated MHRA liaison in relation to medical devices is the Medical Devices Safety Officer with the Medical Engineering Manager having overall responsibility for device management and maintenance, local management being devolved to ward and department managers. 2.4 During the life of the policy, the MHRA may issue alerts that could conflict with the policy, if this occurs, the latest MHRA guidance should be followed Medical Devices Policy (83) / Version 7 / March

6 3. DEFINITION 3.1 A medical device is defined as any product used in the diagnosis, treatment, prevention or alleviation of illness or injury of a patient. A medical device could be a complex CT Scanner or even a simple wooden spatula. A mains electrical extension lead requires testing as a medical device if it is used to connect a medical device or its accessories to the mains electricity supply. References: MHRA Managing Medical Devices April 2015 BS EN : The above definition gives an indication of the difficulty involved in producing a single policy to manage the diverse range of current and future medical devices. 4. MEDICAL DEVICE CATEGORIES 4.1 For the purposes of this policy and to minimise complication, all medical devices will be categorised as follows: The example lists are not exhaustive. Where a device encompasses more than one category, the device will be classed as Category A and identified with a Yellow Asset Label. If in doubt contact the Medical Engineering Manager. Category A - Active devices Management responsibility: User & Medical Engineering (EBME) Identified by a Yellow Asset Label Systematic inventory maintained by EBME Any device powered by means of compressed gas, battery or mains electricity, excluding category C & D devices - examples: physiological monitoring & recording devices, defibrillator, insufflators, light source, surgical diathermy, slit lamp, infusion pump, pressure relief mattress and bed systems, video monitoring system, IR and UV therapy units, ultrasound scanner, laboratory instrumentation, nerve stimulators, physiotherapy devices, compressor type nebulisers, vacuum pump, electronic thermometer etc. Any device powered by means of battery or mains electricity, including accessories - examples: ophthalmoscope; laryngoscope; diagnostic set, etc. Medical Devices Policy (83) / Version 7 / March

7 Any device powered by hand, including accessories - example: Sphygmomanometer etc. Category B - Mechanical devices Management responsibility: User and Estates Departments Identified by a White Asset label Systematic inventory maintained by Estates and/or User department Any device powered by battery, mains electricity, hand or not powered - examples: wheelchair, bed / couch, wall mounted gas / vacuum outlets (Estates department), crutch, walking frame, (User department). Category C - Medical Gas therapy or Anaesthetic agent devices Management responsibility: User and Medical Engineering Department. Identified by yellow asset label. Systematic Inventory maintained by Medical Engineering. Any device not powered by battery or mains electricity and used in the administration or control of medical gas or anaesthetic agents - examples: gas pressure regulator/flow meter, anaesthetic machines and vaporisers etc Category D Active implant devices Management responsibility: Clinical department & Supplier No Asset label Implantation records maintained by Cardiorespiratory department Examples: pacemaker; defibrillator etc Category E - Consumable and Single Use items Management responsibility: User & Purchasing Department No Asset label NO MAINTENANCE No inventory purchasing records Examples: dressings; syringes; giving-sets; surgical laser fibre optics etc Category F Endoscopes (flexible/rigid) Management responsibility: User & Purchasing department No Asset label Inventory maintained by Endoscopy unit Medical Devices Policy (83) / Version 7 / March

8 5. DUTIES/RESPONSIBILITIES 5.1 Medical Director Has overall responsibility for management of medical devices and effectiveness of the management system To oversee medical device incident reporting and learning 5.2 Medical Device Safety Officer (MDSO) Support the local reporting and investigation of adverse incidents involving medical devices. Liaise with the MHRA and NHS England in respect of incident reporting and learning. Act as point of contact for manufacturers and support local actions for Field Safety Notices. Be a member of the National Medical Devices Safety Network. 5.1 Ward / Departmental managers are responsible for ensuring that within their area of responsibility: All medical devices have been correctly accepted for use within the Trust. All medical devices are made available for periodic maintenance to be completed. All device users are appropriately trained, to enable them to test the operational performance of a device prior to use, and monitor its performance during use. The departmental inventory of medical devices is kept up to date. A copy of the User Manual or the full operating instructions is available for each device. Where a medical device is given to a patient for home use, the accompanying instructions for use are evaluated for accuracy. All users are advised when a medical device manufacturer issues revised user instructions, any outdated copies must be removed and destroyed. All users will include patients with a medical device prescribed for home use. All defective devices are taken out of service, reported (telephone number on the Asset label) for appropriate maintenance and attach a Medical Equipment Defect Report Form to indentify the nature of the problem and its contamination status. Medical devices are stored appropriately with all relevant leads and accessories. When a medical device is no longer required, the appropriate disposal policy is followed. Medical Engineering should be informed Medical Devices Policy (83) / Version 7 / March

9 before disposal of any asseted medical equipment for advice on redeployment or sale and to remove it from the central inventory. A manufacturer / supplier must not be allowed to remove any device from the user department without documented authorisation of the appropriate management agency. Medical devices for loan or trial must not be accepted for use in the Trust without the device being the subject of a formal documented acceptance procedure. Where a medical device is being loaned to another ward / department, the details asset number, borrowing department etc. must be recorded. Return details must also be documented. Inform Medical Engineering of any permanent transfer of equipment. 5.2 The Medical Engineering Manager is responsible for: Maintaining a Trust-wide inventory of all medical devices in Category A and Category C, this will include a device maintenance history file. Processing from an engineering standpoint all Pre-Purchase Questionnaires (PPQs). The maintenance, calibration, repair and management of all Category A and category C devices. Acceptance testing of all purchased, donated or loaned Category A and category C devices. The documentation process for all purchased, donated or loaned Category A and category C devices. The Medical Engineering Department will provide a copy of the inventory of Category A and category C devices and when requested. 5.3 Authorised Management Agencies (see paragraph 7) Maintain systematic inventories of reusable medical devices which are within their sphere of responsibility. The maintenance, calibration, repair and management of all medical devices which are within their sphere of responsibility. 5.4 All Equipment users: Carry out user checks before use as detailed in the device instruction manual. Ensure device has appropriate and in date service label or a Repair Only label attached. Medical Devices Policy (83) / Version 7 / March

10 Do not use unless adequately trained. Ensure the correct and appropriate accessories are used. For category A, B and C devices ensure that an asset or on loan label is attached, report any without to Medical Engineering or Estates as appropriate. Report any faults, damage or performance issues to the appropriate maintenance authority. Include fault description, asset number and location. Raise incident reports in line with the Incident and Serious Incident Management Policy and Process, identify and quarantine any devices and accessories involved. Report the device to the appropriate maintenance authority for investigation (informing them that the device has been involved in an incident). Decontaminate as detailed in instruction manual and local policies. Ensure equipment and accessories are stored safely. 6. DISCIPLINARY ACTION 6.1 Any attempt by any member of staff to interfere with the correct working of a medical device, or to alter its basic electronic configuration without proper authority, may result in disciplinary action. 6.2 Any attempt to gain access to the internal workings of, or to repair, or attempt a repair, on a medical device, by any unauthorised member of staff may result in disciplinary action. 6.3 Each medical device will be subjected to a recognised and documented acceptance procedure prior to deployment within the ward or department. 7. AUTHORISED MANAGEMENT AGENCIES User Department Category D and E devices. The Medical Engineering Dept Category A and C devices The Estates Department Category B devices. HSSU and User Department Surgical Instrumentation The Manufacturer / Supplier Any device requiring specialist installation. Category A, B or C devices will be reported to The Medical Engineering Department and/or The Estates Department prior to use to allow completion of the acceptance procedure. Medical Devices Policy (83) / Version 7 / March

11 References: MHRA Managing Medical Devices April ACCEPTANCE PROCEDURE 8.1 A medical device will not be deployed for use until the requirements of this policy have been fulfilled. 8.2 Any medical device new to the Trust will be checked that it is suitable for its intended purpose, meets the statutory safety requirements and performs in accordance with the manufacturer s documented specification. 8.3 Once the device has successfully completed this procedure, it will be labelled accordingly, See section 13, Labelling. 8.4 Medical Engineering will complete and document technical and safety acceptance tests and procedures with clinical acceptance being completed and documented by clinical staff in the user environment. 8.5 For any device that is being purchased, a free issue or donated as new: Each device will be acceptance tested by the Authorised Management Agency with any relevant details being included on the Trust Asset Register. Free issue devices will be subject to an Indemnity Agreement and accompanied by a valid, NHS Delivery Note, Issued by Medical Engineering, for category A and C devices. During the warranty period, the Authorised Management Agency will assess and organise any Planned Preventive Maintenance (PPM) requirement and initiate a device maintenance history file. Category A and C The Medical Engineering Department Category B The Estates & Facilities Department 8.6 For any device that is not new, but is to become a permanent acquisition, from a source other than the manufacturer / supplier. Each device will be treated as new for acceptance purposes but will fail the procedure if delivered without: User Manual or written instruction for use Written instructions for cleaning and decontamination Medical Devices Policy (83) / Version 7 / March

12 Service History Confirmation of the manufacturer / supplier s continuing support 8.7 For any device upon return, after a period of loan external to the Trust, or upon return from a repair or modification by the manufacturer / supplier and before redeployment within a ward or department, all: Category A and C devices will be examined by the Medical Engineering Department. Category B devices will be examined by the Estates & Facilities Department This will ensure that: o It is complete o It is undamaged o It is functionally sound and fit for its intended purpose o Its maintenance status is current o Its decontamination status is known o This process will be documented with any inspection / test being added to the device maintenance history file. 9. DEVICES ON LOAN, ON TRIAL OR HIRED 9.1 A medical device must not be deployed for use until the requirements of this policy have been fulfilled. 9.2 For any device that is to be On Loan or On Trial for use within The Trust: 9.3 Each device will be acceptance tested as new by the Authorised Management Agency. Acceptance tests will not be performed unless the Manufacturer / Supplier is a signatory of the current NHS Master Indemnity Agreement or will complete the local Indemnity agreement and Delivery Note. 9.4 Where the device is being loaned with a view to future purchase, the supplier must forward a Pre-Acquisition Questionnaire (PAQ) to the Medical Engineering Manager before the device is delivered. 9.5 Once the device has successfully completed this procedure, it will be labelled and commissioned into service. See section 13, Labelling. 9.6 Indemnity Forms and Delivery Notes are held and administered by the Medical Engineering Department. The procedure for Category A and C devices will normally be completed within the Medical Engineering Medical Devices Policy (83) / Version 7 / March

13 department. For large equipment requiring assembly by the manufacturer, the procedure can be completed at the user site. 9.7 For all other categories the Indemnity Form will be initiated by the Medical Engineering Department with the rest of the procedure being completed by the Authorised Management Agency. 9.8 The procedure will be conducted in the presence of the Supplier s representative who should be authorised to sign the Indemnity Form on behalf of the supplier. 9.9 The appropriate maintenance authority should be informed when the loan device is removed from the Trust Any items devices exchanged by the supplier are required to go through the acceptance procedure. All relevant device details will be documented and include: o Maker o Description o Model No. / Batch No. o Serial No. o Department for which the device is being accepted o Date of acceptance for Loan / Trial o Period of Loan / Trial o Current purchase price Documentation that must accompany any device: o User manual or written instructions for use o Written decontamination and sterilisation methods o Current Decontamination Certificate o Current Calibration Certificate 9.11 The manager of the department where the device will be on loan must ensure all staff that are required to use the device have adequate training. 10. TESTING, DECONTAMINATION AND MAINTENANCE OF LOAN DEVICES 10.1 Early delivery or notification (24 hours) prior to use is necessary for completion of the acceptance procedure hours is required where the device must be decontaminated and cleaned prior to use. Decontamination instructions and training must be provided with the device. Medical Devices Policy (83) / Version 7 / March

14 10.3 Following use and where necessary, decontamination should be completed. The device MUST NOT be released to the supplier unless decontamination is completed Arrangements and responsibility for any necessary routine maintenance must be agreed and documented prior to acceptance For any device that is to be loaned by the Trust to an external user: Each device will be tested and documented by the issuer prior to issue, to ensure proper operation and that the decontamination and maintenance status are known. Where the loan period extends beyond the next maintenance date, arrangements must be in place to return the device to allow such maintenance to be performed. Arrangements must be in place, and documented, for the return of the device after treatment is completed. The device must be tested prior to redeployment The duration of the loan and all identifying details (Asset No.) of the device, patient or organisation will be recorded For any device that is being Hired for use within The Trust: Each device will be acceptance tested as new by the Authorised Management Agency. Only devices that are the subject of a current Pre-Acquisition Questionnaire (PAQ) will be accepted. Hiring of new devices may be delayed whilst the PAQ requirement is actioned. 11. PRESCRIPTION DEVICES 11.1 For any device that is being loaned to or prescribed for a specific patient: The prescription of any device is the responsibility of the prescribing professional. Only staff with appropriate professional qualifications and experience will make prescribing decisions. The prescribing professional should request administrative and / or technical support to ensure patient safety and that the crossing of professional boundaries is avoided. The patient or the patient s representative must be given a copy of the manufacturer s operating instructions and be properly trained in the safe use of the device and how to perform any daily maintenance tasks. Medical Devices Policy (83) / Version 7 / March

15 Arrangements must be in place and documented to cover technical maintenance and how the user can gain access to any necessary replacement consumable items. Reference: MHRA Managing Medical Devices CHECKLIST FOR PATIENTS DISCHARGED WITH A MEDICAL DEVICE 12.1 General considerations Is the device suitable for home use (have, for example, robustness, back-up systems, alarms been considered if appropriate, modifications needed, patient care and instructions)? Has the person responsible for the use of the device been identified, i.e. is it the patient and / or carer? Is the loan device scheduled maintenance compatible with the loan period? Has the device been fully tested with confirmed functionality and fitness for purpose? 12.2 Patient / Carer instructions Does the patient / carer know the name of the device? Does the patient / carer know how to set up the device in the home? Has the patient / carer been trained in the use and functions of the device? Has the patient / carer been provided with written instructions specifically about the device? Has the patient / carer been trained in how to deal with fail-safe features, e.g. alarms? Has the patient / carer been trained in the care of the device? Does the patient / carer require accessories? If so, does the patient / carer know where to obtain these and how often? Is maintenance required? If so, is the patient / carer aware and in possession of instructions about how this will be achieved? Does the patient / carer have a point of contact in the Trust for any queries? If relevant, does the patient/care have a contact point in case of emergency? Medical Devices Policy (83) / Version 7 / March

16 12.3 Return Does the patient / carer know when to return the device? Does the patient / carer know where to return the device once treatment is complete, to whom and at what time? 13. LABELLING 13.1 All necessary labels will be attached during the acceptance procedure. If the labels are missing or out of date the device should not be used until corrective action is taken Category A & B & C devices owned by or on permanent loan to the Trust will display an Asset label It is not always possible to attach a label to devices in categories C and D due to their physical nature, usage and or rapid turnover Category E devices should be stored with the original label and or packaging The Asset identification label, will indicate The device unique identity number Telephone No. for use when requiring maintenance/repair FOR REPAIR CONTACT MEDICAL ELECTRONICS PHONE ext 5407 ASSET No Next Service Due label: A label that is renewed during planned preventive maintenance (PPM) indicating the date that the device is next due for maintenance. Medical Devices Policy (83) / Version 7 / March

17 No Maintenance Required label: NO MAINTENANCE REQUIRED REPAIR ONLY An alternative to the Next Test Due label, which indicates that the device does not require planned preventive maintenance (PPM), but will be repaired by Medical Engineering as required. Equipment on Loan for Trial or Testing label: o This label identifies a device as being On Loan for Trial or Testing and should not be removed from the device. o The Trust has a legal obligation to ensure that the device is only used within the particular department specified on the Indemnity Form. o The device must not be transferred for use between departments. 14. MAINTENANCE & REPAIR 14.1 Keeping medical devices safe and reliable in use requires daily maintenance, routine maintenance, planned preventive maintenance, repair and calibration. Medical Devices Policy (83) / Version 7 / March

18 14.2 All maintenance, repair and calibration will be documented and performed in accordance with the manufacturer s instructions The Authorised Management Agency will decide the most appropriate strategy for Planned Preventive Maintenance (PPM) External maintenance contracts may be managed directly by the user department or by the authorised management agency by mutual agreement Maintenance Responsibilities Day to Day maintenance o This is detailed in the user handbook and is the responsibility of both the professional user and the end user. Routine maintenance o This is the responsibility of appropriately trained clinical staff. Planned Preventive maintenance, repair and calibration o This is the responsibility of appropriately trained Medical Engineering or Estates staff. o The maintenance authorities may employ contractors to complete maintenance as required. On site maintenance: o During its working life each Category A, B and C device will receive appropriate documented periodic planned maintenance (PPM), calibration and repair. o Any device requiring maintenance or breakdown repair will be removed from service and reported to the Authorised Management Agency for action. o Category A and C The Medical Engineering Department, Phone ext o Category B The Estates & Facilities Department, report via intranet o It is the responsibility of an appropriately trained member of the ward or department staff to check any medical device before it is returned to use after repair or maintenance. This will ensure that the work has been completed, the device functions correctly and that the controls are reset for operational use. o Where the service was provided by an external maintenance organisation, the service report must be signed and Medical Devices Policy (83) / Version 7 / March

19 forwarded to The Medical Engineering Department for inclusion in the maintenance history file. o The manufacturer / supplier or contractor shall not be allowed to remove or replace any device without liaison with The Authorised Management Agency, appropriate documentation and authorisation. Any replacement or additional device must be subjected to an acceptance procedure. See section 8, Acceptance Procedure. Off site maintenance: 15. TRAINING o Any device, that is to be sent off site for maintenance, repair or modification, must have appropriate documentation and be channelled through the appropriate Management Agency. o In all cases the device will be subjected to appropriate decontamination and documentation Refer to Medical Devices Training Policy 15.2 Most healthcare professionals use medical devices. Unfortunately, adverse and critical incidents do occur and some have serious consequences for the patient, staff and property Whilst some incidents are due to problems with the device, many more result from user error or the breakdown of internal management systems 15.4 The following checklist identifies issues that ALL healthcare professionals should ask of themselves before they use a medical device. Do I know how to handle the medical devices within my ward / department? Do my junior colleagues know how to use the devices? What preparation have I been given in how to use a particular medical device, was the preparation formalised and recorded or did I just pick it up as I went along? How was my competency to use the device safely assessed? Am I familiar with the instructions on how to use the device and do I understand any attached warning labels? When was the device serviced last? How do I report a defective device, and to whom? Medical Devices Policy (83) / Version 7 / March

20 Do I know who is responsible for risk management within the Trust? Do I know how to report an adverse / critical incident? Do I know who my MHRA Liaison Officer is? Do I have access to MHRA Device Bulletins of relevance to the devices within my area of practice? Do I read and take note of Safety Alerts/Notices? 15.5 Responsibility of Users The Medical Engineering Department can provide operational but not clinical training on Category A and C devices. The equipment supplier will provide user training on initial purchase and equipment will not be put into use until sufficient staff are trained. Professional user: o Refer to Medical Devices Training Policy End-user (patient/carer): o Training and written instructions must be given by the professional user, to a patient or carer who will use a medical device unsupervised at home, to enable them to use the device safely and effectively, to perform user maintenance and to report a defective device. o Ethnic origin and language of the patient should be accommodated. Engineering department staff: o Engineering staff will receive appropriate device technical training, organised in-house or through the manufacturer / supplier. Reference: MHRA Managing Medical Devices April DECONTAMINATION AND TRANSFER OF DEVICES The Medical Engineering Department will be advised of the asset number and the new location of any Category A or C device if transfer is to be long term or permanent. Medical Devices Policy (83) / Version 7 / March

21 The Estates & Facilities department will be advised of the asset number and the new location of any Category B device if transfer is to be long term or permanent. Short term loans of equipment between department should be recorded on the departments local inventory. For equipment borrowed from the Medical Equipment Library the loan should be recorded in line with the library operational policy Infection control: Before being transferred between patients, departments, repair agencies or the patient s home, each device must receive appropriate decontamination; this will include status certification as necessary Devices being prescribed / loaned to a patient for home use: Home means private dwellings, care home or nursing home. Where a device is being prescribed or loaned to a patient for home use, the patient and device details will be documented. It is the responsibility of the issuing ward/department to ensure that the device is fit for its intended purpose and its maintenance and decontamination status is known. Arrangements must be in place and documented to cover any necessary maintenance / repair. References: MHRA Managing Medical Device April SURGICAL INSTRUMENTS AND EQUIPMENT Surgical Instruments and trays have a unique identity number located on a barcode tag or label which must remain with the instrument or tray at all times. HSSU maintains the inventory register for these instruments and trays Surgical Instruments and equipment requiring decontamination must be returned to the Trust s central decontamination unit (HSSU) for decontamination. Medical Devices Policy (83) / Version 7 / March

22 17.1 Collection, Handling and Delivery of Surgical Instruments and Equipment. The unique identity number located on a barcode tag or label (which must remain with the instrument or tray at all times), is used to track the item through the decontamination process to the individual patient Collection Used instruments and sets must be returned to HSSU in a used instrument bag, container or trolley clearly marked to reduce the risk of cross contamination and damage Decontamination Upon receipt within HSSU the instruments are sorted and undergo a decontamination process. The stages of the decontamination process are as follows:- Cleaning The physical removal of dirt, grease and organic matter which reduces the number of micro organisms present. Cleaning must precede disinfection and sterilisation. This is undertaken via automated washer disinfector machines. These machines are maintained and undergo routine testing in accordance with Hospital Technical Memorandum 01. If the instrument is unable to withstand the automated cleaning process, Manufacturers instructions will be followed. Inspection Visual Inspection of the instrument/equipment to ensure all visible contamination has been removed. The instruments are then assembled, packed and a tracking label applied. Sterilisation The process of rendering an article completely free from living organisms. This stage of the process is undertaken using porous load steam sterilisers. The instruments are subjected to steam under pressure for between 3 to 3.5 minutes at a temperature of 34 to 37 degrees centigrade. The sterilisers are subject to maintenance and routine testing in accordance with HTM01. Checks are made prior to release of the instrument/ set to ensure the process has been completed correctly. Medical Devices Policy (83) / Version 7 / March

23 Distribution and storage Decontaminated equipment is returned to the user department in containers / trolleys to prevent cross contamination and damage. Decontaminated equipment must be stored in a clean, dry environment above floor level. Routine stock control must be undertaken as decontaminated reusable equipment has a shelf life of 12 months after which it must be returned to HSSU for reprocessing. 18. ADVERSE INCIDENTS 18.1 Refer to the Incident and Serious Incident Management Policy and Process Where the incident involves a medical device, the device must be reported to Medical Engineering or appropriate maintenance authority for technical investigation The Medical Engineering Manager will be responsible for the production of any necessary technical report for inclusion in the Adverse Incident file for category A or C devices Medical Engineering can also be consulted for assistance and guidance as required The MDSO will be automatically notified by the electronic reporting system of all incidents involving medical devices and will monitor for incident trends, assist in investigations and report as required to the MHRA Incident relating to a device or accessory The device must be withdrawn from service, quarantined, clearly marked ADVERSE INCIDENT and identified as a BIO-HAZARD if necessary. All evidence will be retained and protected. The relative position / setting of any controls must be recorded. Medical Engineering will be advised and requested to examine the device and produce a report to be uploaded to the Datix incident record. If appropriate, users of similar devices within the Trust should be advised as soon as practicable that a possible hazard exists and be warned to be extra vigilant. The device asset number and the accessory details will be included in any report. Medical Devices Policy (83) / Version 7 / March

24 Each device should receive appropriate decontamination unless the procedure is likely to destroy evidence, in which case it will be protected and appropriately labelled Incident relating to a consumable The item will be withdrawn from service, quarantined, clearly marked ADVERSE INCIDENT, kept secure and if necessary identified as a BIO-HAZARD. All evidence will be retained and protected. The asset number of any associated medical device will be recorded. Each item should receive appropriate decontamination unless the procedure is likely to destroy evidence, in which case it will be protected and appropriately labelled. All identifying details, including batch and lot numbers and the Materials Management item-code, will be reported to the internal supplier for any necessary action. All products of the same batch and lot numbers should be withdrawn from service, labelled NOT FOR USE, secured from use until continued use is authorised by the internal supplier In all cases, suspect items should not be repaired in-house, by a third party, returned to the manufacturer / supplier or discarded before a local investigation has been carried out. The manufacture / supplier should be informed promptly and allowed to inspect the items. The inspector must be accompanied by an appropriate member of Trust staff DISPOSAL 19.1 Medical devices must not be disposed of without following this policy The Medical Engineering Department will decommission all portable category A and C medical devices prior to disposal Decommissioning will ensure that the medical device is risk and environmentally safe for disposal and any electronic patient data has been removed 19.4 Any medical device (Yellow Asset Label), which through age, inability to effectively fulfil its intended purpose, becomes unreliable in use, uneconomical to maintain or cannot be easily cleaned, will be reported to The Medical Engineering Department for investigation prior to possible withdrawal from service and replacement action being taken For all other equipment, the Local Disposal Policy must be followed to facilitate updating the Trusts Asset Register. Medical Devices Policy (83) / Version 7 / March

25 19.6 Disposal may be by one of the following methods Transfer of ownership by sale via an approved auction house. Disposal as waste The selling of medical devices must be notified through the Medical Equipment Group and the Director of Finance to ensure the asset is written off as appropriate in accordance with Standing Financial Instructions. 20. EFFECTIVE MONITORING Effective monitoring of this policy will be conducted by the Medical Engineering Manager by monitoring the following: Periodic equipment maintenance/inspections Completion of work equipment risk assessments Adverse incident reports highlighting any incidents that involve medical devices Control measures taken to ensure the incident does not re-occur A broad based Medical Devices & Product Users Group chaired by the Deputy Chief Nurse will meet bimonthly to discuss all aspects of medical device management, including trends in adverse incidents and cases of non-compliance. 21. POLICY REVIEW The policy will be amended as necessary to meet MHRA and operational requirement. It is not the author s intention to consult for every simple amendment; however, a full review subject to consultation will take place every three years. The most up to date version will always be found on the intranet Medical Devices Policy (83) / Version 7 / March